Insulin has been used to control diabetes in diabetic patients since the discovery of insulin some 70 years ago and is prescribed in many ways. In recent years, insulin has come to be prescribed in one of two different ways to diabetic patients:
1. The more commonly used conventional method uses injections of (a) long-acting or (b) mixed short-acting and long-acting insulins once or twice daily. PA1 2. In an intensive method, which hoped to correct the deficiencies of the conventional method, either (a) mixed long-acting insulin plus regular insulin (b) and/or regular insulins are given 3 to 5 times a day with more intensive testing and professional encounters than with the conventional method. The goal of such therapy is to approximate the natural non-diabetic state of insulin secretion. The insulin dosage is adjusted up and down according to a set algorithm based on the results of frequent blood tests. The patient and the professional team participate in such testing. PA1 Type 1 diabetes, which used to be called juvenile onset diabetes, occurs in 3-5% of diabetics. Also, up to 10% of type 2 insulin-requiring diabetics may actually be adult-onset type 1. PA1 Type 2 diabetes comprises 80-95% of all diabetics. This type of diabetes used to be called adult or maturity onset diabetes. PA1 Secondary diabetes, in which the diabetes is a secondary manifestation of another ailment, comprises the rest. PA1 Unfortunately, there is compelling evidence that hyperinsulinemia may be associated with accelerated atherosclerosis, hypertension, hypertriglyceridemia and reduced high density lipoprotein cholesterol. Insulin per se is also capable of causing insulin resistance. This presents clinicians with a major therapeutic dilemma particularly in type 2 diabetic subjects. Do they attempt to normalize the blood glucose level, knowing that hyperglycemia is associated with microvascular (nephropathy, retinopathy, neuropathy) complications while recognizing that hyperinsulinemia per se may promote a more atherogenic profile?. A solution to this difficult question is not at hand. PA1 Finally, if Syndrome X can be produced by the rather mild insulin resistance and hyperinsulinemia found in the apparently normal persons described by Zavaroni et al, it will be an alarming thing for diabetologists. They rarely normalize the elevated plasma glucose levels caused by the insulin deficiency or insulin resistance in their patients with diabetes mellitus, and their efforts often produce hyperinsulinemia. PA1 1. The ability to reverse an out-of-control diabetic to a compensated state without requiring weight loss, change in exercise habits or change in life style. PA1 2. The complete prevention of hypoglycemia of any severity, even in those diabetics who were already experiencing hypoglycemia under someone else's care. PA1 3. Since insulin dosages are either precisely sufficient for the patient's need on any one day or about one unit less per dose while on the insulin-plus-sugar therapy of the present invention, iatrogenic hyperinsulinemia is prevented. PA1 4. Patients with pre-existing vascular and neuropathic complications frequently exhibit a significant reversal of these complications in a matter of weeks. PA1 5. Nearly any diabetic can easily learn to follow the present method. Peace of mind and preserved quality of life flow from the simplicity and predictability of this method. PA1 6. The cost of diabetic care under this method is dramatically reduced. PA1 Before meals (3 times a day); PA1 2 hours after each meal (3 times a day); and PA1 At bedtime (1 time a day). PA1 1. The counter-regulatory hormones excess, the insulin antagonist, has now been eliminated with the elimination of the stress of uncontrolled diabetes. PA1 2. Insulin action becomes greatly enhanced because insulin resistance is now reduced by the elimination of hyperglycemia and the elevated counter-regulatory hormones. PA1 3. The suppressed and exhausted pancreas caused by the previous hyperglycemia and the lack of diabetic control has now been revitalized. PA1 4. Adequate insulinization has controlled the excessive hepatic glucose production. PA1 5. In new type 2 diabetics and in any diabetic who has a residual ability of the pancreas to produce insulin (as measured by the C-peptide blood levels), pancreatic insulin production can be made to increase. In type 2 diabetics, especially of recent onset, increased production of insulin can be stimulated to match the need if the extra demand is made small (1-2 units early in the treatment and only 1 unit later on), much like training a muscle to a greater strength. An awakened pancreas can produce the needed units usually in 1 day, but may take up to 3 days.
This method has not been deemed satisfactory for the control of diabetes mellitus because hypoglycemias continued to occur. The insulin dosage has often tended to increase over time and vascular complications of diabetes tended to appear prematurely with resulting chronic disabilities and premature death. Good control, which is defined by many clinicians as normal or near normal blood glucose levels especially before breakfast but also before and after meals, was rarely achieved by this method.
To date, no unequivocal improvement in results has been demonstrated and severe hypoglycemias have occurred even more frequently in such patients.
In recent years, blood sugar tests have been utilized to access the adequacy of insulin treatment and to adjust the insulin dosage accordingly.
Urine tests for glucose have lost their prior prominence because they gave rough estimates of the blood glucose values and were therefore deemed as inadequate methods for monitoring diabetes. Urine tests were discarded by many diabetologists.
The diet is always an important and necessary part in the control of diabetes. In recent years, the diet consisted of a lower total fat and lowered total saturated and polyunsaturated fats. A higher carbohydrate intake was needed to meet calorie requirements since the proteins were fixed at 15-20% of the total calories. Monounsaturated fats were given more prominence in order to cut down on the carbohydrates because carbohydrates in short term studies have tended to increase the triglyceride levels and to lower the levels of high density lipoproteins which carry the "good cholesterol".
Generally, the diabetic diet is divided into 3 meals and 2-4 snacks. Snacks are given between meals and at bedtime, as part of the total prescribed calories, in order to prevent hypoglycemias. The diet is also used for weight reduction, which is beneficial to the diabetic. However, the success of diet therapy is limited in scope and duration and only about 20% derive more lasting benefits from it.
In all of these known methods of controlling diabetes, iatrogenic hypoglycemias have continued to occur and the vascular complications of diabetes have not been prevented, arrested or reversed. Besides, the set goals of normalization of the elevated plasma glucose were achieved only rarely.
As is known and as used in the present application, the following definitions apply: